510(k) K964770 ยท HGM System, Monitoring, Perinatal
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Feb 21, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964770
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.